Devices and methods for inserting a vertebral fixation member

ABSTRACT

Devices, systems, and methods for inserting a vertebral stabilization member, such as a rod. The insertion device includes an outer guide tube, a pin assembly including a pin and a pusher member extending therethrough. The insertion device is configured to actuate a rod between a first orientation and a second orientation angled with respect to the first orientation in order to position the rod in an appropriate location for attachment to bone.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a divisional application of U.S. patentapplication Ser. No. 15/662,995 filed on Jul. 28, 2017, which is acontinuation of U.S. patent application Ser. No. 14/516,631 filed onOct. 17, 2014, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/413,058 filed on Mar. 27, 2009, now U.S. Pat.No. 8,900,238, the entire disclosure of which is incorporated herein byreference in its entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods forinserting a vertebral fixation member, and more particularly, but notexclusively, to rod insertion devices and methods.

BACKGROUND OF THE INVENTION

Many types of spinal irregularities can cause pain, limit range ofmotion, or injure the nervous system within the spinal column. Theseirregularities can result from, without limitation, trauma, tumor, discdegeneration, and disease. Often, these irregularities are treated byimmobilizing a portion of the spine. This treatment typically involvesaffixing a plurality of screws and/or hooks to one or more vertebrae andconnecting the screws or hooks to an elongate rod that generally extendsin the direction of the axis of the spine.

Treatment for these spinal irregularities often involves using a systemof pedicle screws and rods to attain stability between spinal segments.Instability in the spine can create stress and strain on neurologicalelements, such as the spinal cord and nerve roots. In order to correctthis, implants of certain stiffness can be implanted to restore thecorrect alignment and portion of the vertebral bodies. In many cases, ananchoring member such as a pedicle screw along with a vertical solidmember can help restore spinal elements to a pain free situation, or atleast may help reduce pain or prevent further injury to the spine.

As the science and technology of spine surgery continues to progress,there is an increasing interest in developing alternative, minimallyinvasive, methods to conventional “open” spine surgery. The goals ofthese less invasive alternatives are to avoid the surgical exposure,dissection, and retraction of muscles and tissues that is necessary with“open” surgery. In general, a minimally invasive spine surgery systemshould be able to perform the same procedure as the traditional opentechnique, but through smaller incisions instead of one longer incision.As a result, some physicians feel that using a minimally invasive spinesurgery system generally causes less soft tissue damage, reduces bloodloss and reduces recovery time. In addition, patients generally preferthe smaller scars that are left using a minimally invasive approach.

Historically, spine fusion surgery including pedicle screw fixation withdeep placement of rods has been one area that has presented significantchallenges for minimally invasive approaches. However, advancement intechnologies such as fluoroscopy and improvements in optics havecontributed to the advent of a few minimally invasive spine fusionsurgery techniques.

SUMMARY OF THE INVENTION

Devices, systems, and methods for inserting a vertebral stabilizationmember are disclosed. The vertebral stabilization system may include anelongate stabilization member, such as a rod, positioned between one ormore anchors, such as pedicle screws with tulip heads. After the pediclescrews have been implanted, the rod may be inserted, reduced, and/orlocked into the tulip head. The rods may be inserted for example usingan insertion device, which may be used to introduce the rod to thesurgical site using, for example, an open, mini-open, percutaneous orminimally-invasive method. For minimally invasive surgical procedures,for example, there may be limited access locations for the rods. Forexample, if a sleeve is used during the procedure, the rod may be placedthrough or proximate to the sleeve. In the alternative, one or moreextension tabs may be connected to the anchor, and the rod may be placedthrough or proximate to the extension tabs. The position of theinsertion device and the rod preferably eases rod insertion whilelimiting skin, muscle, and tissue damage.

In addition, many existing rod holders are fixed position with limitedfreedom of movement, which increases the potential for non-ideal rodplacement. This may result in additional or elongated incisions,excessive rod reduction, or complete removal of the rod and reinsertionincreasing muscle and tissue damage. Accordingly, an articulating designfor the insertion device may be provided allowing for articulatingmotion between an initial, insertion orientation and a final, installedorientation. This articulating motion results in more controlled andconsistent rod insertion and a reduction in muscle and tissue damage,for example, in one-to-two level fusion cases. The insertion device canmaintain and control the rod position without requiring any additionalincisions.

According to an embodiment, an insertion device is suitable forinstalling an elongate stabilization member in a first orientation andpivoting the elongate stabilization member to a second orientation, forexample, angled at about 90° relative to the first orientation. Theinsertion device includes an outer guide tube, a pin assembly, and apusher member. The outer guide tube has an elongate body extending froma first end to a second end and has a central longitudinal openingextending therethrough. The pin assembly includes a pin extendingthrough the central longitudinal opening of the outer guide tube. Thepin has a first end engaged with a thumb wheel and a second endconfigured to engage a clamping element, such that when the thumb wheelis rotated, the pin linearly moves and engages a portion of the clampingelement. The pin assembly may be configured to enable locking andunlocking of the elongate stabilization member to the insertion device.The pusher member extends through the central longitudinal opening ofthe outer guide tube having a first end connected to a handle and asecond end connected to the clamping element, such that when the handleis depressed, the pusher member linearly moves to cause the elongatestabilization member to pivot.

The insertion device may have one or more of the following features, forexample: a first handle connected to the pusher member by a firstlinking element and a second handle connected to the outer guide tube;the first and second handles connected together by a ratchet in theshape of a wheel having a plurality of teeth positioned around theperiphery of the wheel; the first and second handles locked in positionrelative to one another by depressing a locking member having teethcorresponding to and designed to engage the ratchet; and the pushermember connected to the clamping element with a second linking elementconfigured to pivot in response to linear motion of the pusher member.

According to one embodiment, a minimally invasive vertebralstabilization system includes a first anchor, an elongate stabilizationmember, and a stabilization member insertion device. The first anchor isdeliverable to a vertebral body of a patient through a first openingwith at least one extended tab connected thereto. The at least oneextended tab defines an open central portion and a central longitudinalaxis. The elongate stabilization member extends from a proximal end to adistal end.

The stabilization member insertion device releasably and rotatably linksto the elongate stabilization member. The stabilization member insertiondevice is configured and dimensioned to be received within the opencentral portion such that the insertion device is moveable along thecentral longitudinal axis. The elongate stabilization member may becantilevered off the stabilization member insertion device such that atleast a portion of the elongate stabilization member is positionedoutside the at least one extended tab. This configuration may allow forlonger rods to be utilized.

The elongate stabilization member is deliverable in a first orientationsubstantially parallel to the central longitudinal axis of the opencentral portion; and, independent of movement along the centrallongitudinal axis, the elongate stabilization member is rotatablyactuatable by the stabilization member insertion device to extend in asecond orientation angled with respect to the first orientation toposition the stabilization member in relation to the first anchor. Theinsertion and articulation of the elongate stabilization member may becontrolled with the use of fluoroscopy, for example, to help guide axialand rotation movements.

In alternative to providing an instrument-sleeve or separate sleeve, theanchor may be connected to one or more extended tabs. The extended tabsmay extend upwardly from an upper portion of the anchor. The extendedtabs may have an elongate curved body, for example, to mimic a sleeve.The extended tabs may include a pair of diametrically opposed extendedtabs defining opposed longitudinal openings. The longitudinal openingsmay provide lateral access to and from the open central portion. Forexample, a portion of the elongate stabilization member may beextendable through the longitudinal openings. The extended tab may be amulti-part component. For example, the extended tab may include a firstextension element connected to the first anchor at a break point and asecond extension element connected to the first extension element. Thesecond extension element may be connected to the first extension elementvia a dovetail and/or welded connection, for example.

Instead of positioning the elongate stabilization member through theopen central portion, the elongate stabilization member may becantilevered off the stabilization member insertion device. Inparticular, at least a portion of the elongate stabilization member isnot positioned within the open central portion and is positioned outsidethe at least one extended tab. For example, the proximal end of theelongate stabilization member may not be contained within the opencentral portion in the first orientation.

The minimally invasive vertebral stabilization system may include asecond anchor deliverable to a vertebral body of a patient through asecond opening with one or more extended tabs connected to the secondanchor. The extended tabs connected the second anchor may be the same orsimilar to the extended tabs connected to the first anchor. The firstand second anchors may include a bone fastener, such as polyaxialscrews, bone screws, hooks, etc. with a coupling element attachedthereto. The coupling element, such as a tulip element, yoke, or thelike, may be provided for coupling the elongate stabilization member tothe bone fastener. Clamp and/or wedge elements may be used to secure thebone fastener in the coupling element. A locking cap may be used tosecure the rod in the coupling element. The rod should be seated firmlyin the coupling element in order for the elements of the fixation deviceto be secured. The stabilization member insertion device may be operableto place the stabilization member between the first and second anchors.

The elongate stabilization member may be in the form of a rod. The rodmay have a substantially straight shape or a curvilinear shape. The rodmay have at least one indentation along its length, for example, suchthat the stabilization member insertion device may clampably link to thestabilization member about the indentation(s). The proximal end of therod may be configured and dimensioned to interact with the stabilizationmember insertion device. The proximal end of the rod may be angled withrespect to a longitudinal axis of the rod, and the proximal end maydefine a concave surface.

The elongate stabilization member may be releasably clampable to theinsertion device between first and second clamping members at a clampinglocation spaced from a midline of the elongate stabilization member. Thefirst clamping member may include a first generally cylindricalprotrusion insertable into a distal portion of the insertion device andthe second clamping member may include a second generally cylindricalprotrusion insertable into the distal portion of the insertion device.The first and second clamping members may be coupled by a pin extendingthrough a first and second opening in the first and second clampingmembers, respectively.

According to another embodiment, a minimally invasive vertebralstabilization system includes an anchor, an elongate stabilizationmember, and a stabilization member insertion device. The anchor isdeliverable to a vertebral body of a patient with one or more extendedtabs connected thereto. The extended tab includes a first extensionelement connected to the first anchor at a break point and a secondextension element connected to the first extension element. The extendedtab defines an open central portion and a central longitudinal axis. Theelongate stabilization member extends from a proximal end to a distalend.

The stabilization member insertion device releasably and rotatably linksto the proximal end of the elongate stabilization member. Thestabilization member insertion device is configured and dimensioned tobe received within the open central portion such that the insertiondevice is moveable along the central longitudinal axis. The elongatestabilization member is cantilevered off the stabilization memberinsertion device such that at least a portion of the elongatestabilization member is positioned outside the second extension elementof the at least one extended tab.

The elongate stabilization member is deliverable in a first orientationsubstantially parallel to the central longitudinal axis of the opencentral portion; and, independent of movement along the centrallongitudinal axis, the elongate stabilization member is rotatablyactuatable by the stabilization member insertion device to extend in asecond orientation angled with respect to the first orientation toposition the stabilization member proximate to the anchor. The secondorientation may be angled at about 90° relative to the firstorientation.

According to another embodiment, a minimally invasive vertebralstabilization system includes an anchor, an elongate stabilizationmember, and a stabilization member insertion device. The anchor isdeliverable to a vertebral body of a patient with one or more extendedtabs connected thereto. The extended tab defines an open central portionand a central longitudinal axis. The extended tabs include a pair ofdiametrically opposed extended tabs defining opposed longitudinalopenings. The longitudinal openings provide lateral access to the opencentral portion. The elongate stabilization member extends from aproximal end to a distal end. The stabilization member insertion devicereleasably and rotatably links to the proximal end of the elongatestabilization member. The stabilization member insertion device isconfigured and dimensioned to be received within the open centralportion such that the insertion device is moveable along the centrallongitudinal axis. The elongate stabilization member is cantilevered offthe stabilization member insertion device such that at least a portionof the elongate stabilization member is positioned outside of one of thelongitudinal openings. The elongate stabilization member is deliverablein a first orientation substantially parallel to the centrallongitudinal axis of the open central portion; and, independent ofmovement along the central longitudinal axis, the elongate stabilizationmember is rotatably actuatable by the stabilization member insertiondevice to extend in a second orientation angled with respect to thefirst orientation to position the stabilization member proximate to theanchor.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more readily understood with reference to theembodiments thereof illustrated in the attached drawing figures, inwhich:

FIG. 1 is a perspective view of one embodiment of a stabilization memberand insertion device shown during on embodiment of an installationmethod according to the present invention;

FIG. 2 is a perspective view of one embodiment of a stabilization memberinsertion device according to the present invention;

FIG. 3 is an exploded view of one embodiment of a screw;

FIG. 4 is an exploded view of another embodiment of a screw;

FIG. 5 is an assembly view of the embodiment of the screw of FIG. 4;

FIGS. 6-7 are side and front views of one embodiment of an accesssleeve;

FIG. 8 is an exploded view of one embodiment of the insertion device ofFIG. 2;

FIG. 9 is a perspective view of one embodiment of a stabilization memberaccording to the present invention;

FIGS. 10-11 are enlarged side and top views of the stabilization memberof FIG. 9;

FIGS. 12-13 are perspective views of left and right clamp members,respectively;

FIG. 14 is a perspective view of a longitudinal pin assembly;

FIG. 15 is an enlarged partial perspective view of the insertion deviceof FIG. 2 shown in a first position;

FIG. 16 is an enlarged partial perspective view of the insertion deviceof FIG. 2 shown in a second position;

FIG. 17-18 are side and rear partial perspective views of the insertiondevice of FIG. 2 shown in the second position;

FIG. 19 is a partial cross-sectional view of the insertion device ofFIG. 2, shown with the clamp assembly unclamped to the stabilizationmember;

FIG. 20 is a partial cross-sectional view of the insertion device ofFIG. 2, shown with the clamp assembly clamped to the stabilizationmember;

FIG. 21 is a partial cross-sectional view of the insertion device ofFIG. 2 shown in a first position;

FIGS. 22-24 are partial cross-sectional views of the insertion device ofFIG. 2 shown in second, third and fourth positions, respectively;

FIG. 25 is a perspective view of another embodiment of a stabilizationmember and insertion device shown during another embodiment of aninstallation method according to the present invention;

FIG. 26 is a front view of another embodiment of an insertion device;

FIG. 27 is a side view of the insertion device shown in FIG. 26;

FIGS. 28A-28E depict an embodiment of a coupling element having extendedtabs that may be removed after the rod is locked in place;

FIGS. 29A and 29B are close-up side views of the insertion apparatusshown in FIG. 27 with (FIG. 29A) and without (FIG. 29B) an extended taband tulip present;

FIGS. 30A and 30B are close-up side views of the insertion apparatusshown in FIG. 27 with the elongate rod articulated 90° with (FIG. 30A)and without (FIG. 30B) an extended tab and tulip present;

FIGS. 31A and 31B are close-up side views of the insertion apparatusshown in FIG. 27 with the elongate rod in the initial 0° position withthe pin in a first position enabling the clamp members to pivot apart(FIG. 31A) and with the pin in a second position enabling the clampmembers to securely hold the rod (FIG. 31B);

FIGS. 32A and 32B are close-up side views of the insertion apparatusshown in FIG. 27 with the elongate rod articulated 90° with the pin inthe second position securely holding the rod (FIG. 32A) and with the pinin the first position allowing the rod to be released (FIG. 32B);

FIGS. 33A-33C are front, side, and cross-sectional views, respectively,of another embodiment of an insertion device;

FIGS. 34A and 34B are close-up side and cross-sectional views,respectively, of the insertion apparatus shown in FIG. 33B with theelongate rod articulated 90°;

FIGS. 35A and 35B are cross-sectional views of the insertion apparatusshown in FIG. 33B with the elongate rod in the initial 0° position withthe pin in a first position enabling the clamp members to open (FIG.35A) and with the pin in a second position enabling the clamp members tosecurely hold the rod (FIG. 35B);

FIGS. 36A and 36B are cross-sectional views of the insertion apparatusshown in FIG. 33B with the elongate rod articulated to about 90° withthe pin in a first position enabling the clamp members to open (FIG.36A) and with the pin in a second position enabling the clamp members tosecurely hold the rod (FIG. 36B);

FIGS. 37A-37H depict alternative view of an insertion apparatusaccording to another embodiment, which may be suitable for use in anopen or mini-open procedure; and

FIGS. 38A-38I depict alternative views of an insertion apparatusaccording to yet another embodiment.

Throughout the drawing figures, it should be understood that likenumerals refer to like features and structures.

DETAILED DESCRIPTION

The various embodiments of the invention will now be described withreference to the attached drawing figures. The following detaileddescription of the invention is not intended to be illustrative of allembodiments. In describing the various embodiments of the presentinvention, specific terminology is employed for the sake of clarity.However, the invention is not intended to be limited to the specificterminology so selected. It is to be understood that each specificelement includes all technical equivalents that operate in a similarmanner to accomplish a similar purpose. The features of one embodimentmay be employed with other embodiments as the skilled artisan wouldrecognize, even if not explicitly stated herein.

Referring to FIG. 1, one embodiment of a stabilization member insertiondevice 10 is shown positioned within one embodiment of a sleeve 22 thatis mated to a first anchor 12. A second anchor 14 is shown attached to asecond sleeve 24. A connecting member or stabilization member 16 isshown attached to device 10 and is configured to connect and/or extendbetween the first and second anchors 12, 14 for stabilizing at least aportion of a vertebrae of a patient. According to one variation, firstanchor 12 may be positioned within a body of a patient through any knownsurgical methods, including but not limited to, through a firstminimally invasive or percutaneous opening. Second anchor 14 is alsopositionable within a body of a patient through any known surgicalmethods, including but not limited to, through a second minimallyinvasive or percutaneous opening. In the alternative, first and secondanchors 12, 14 may be inserted through an open, mini-open, or mixed openand minimally invasive procedure. In one embodiment, first and secondanchors 12, 14 are configured to engage first and second vertebra.

Stabilization member 16 is positionable within the body of a patientthrough a first opening in the skin to engage and connect first andsecond anchors 12, 14. According to one embodiment, one of sleeves 22,24 may extend from anchors 12, 14 and facilitate insertion of anchors12, 14 into a vertebral body. Stabilization member 16 may be installedbetween anchors 12, 14 and clamping members, screw caps or set screwsmay be installed for fixation of stabilization member 16 to anchors 12,14. Stabilization member 16 may be installed through any known surgicalmethods including, but not limited to minimally invasively,percutaneously or through an open procedure or non-percutaneously intoreceiving portions or channels 26 of anchors 12, 14. According to oneembodiment, connecting member or stabilization member 16 generallycomprises an elongate rod or shaft. Stabilization member 16 may have anarcuate or curvilinear shape. In alternative embodiments, however,stabilization member 16 can include any configuration known for a rod,implant, or fastener, and can be straight or have any curvature alongits length including a compound curvature. As shown in FIG. 1, astabilization member insertion device 10 may be inserted into sleeve 22to facilitate insertion of stabilization member 16 into anchors 12, 14.Although a second sleeve 24 is depicted in FIG. 1 as being attached toanchor 14, a second sleeve 24 may or may not be connected to secondanchor 14, depending on the preference of a surgeon user.

In one embodiment, stabilization member insertion device 10 isreleasably and rotatably linked to the stabilization member 16 and thestabilization member insertion device 10 is configured and dimensionedto be received within a single sleeve 22, 24 such that the insertiondevice 10 and stabilization member 16 are moveable in the longitudinaldirection within the sleeve to position stabilization member 16 adjacentthe distal end thereof. As will be discussed in more detail below,stabilization member 16 is deliverable through the sleeve in a firstorientation substantially parallel to the axis of the sleeve and isrotatable to a second orientation at an angle with respect to the firstorientation. Furthermore, the stabilization member 16 is rotatablyactuatable by insertion device 10 independent of movement along the axisof the sleeve, i.e. the stabilization member 16 may be rotated byinsertion device 10 anywhere along the length of the sleeve. Such afeature may be particularly advantageous, for example, to adjust thepathway or route that the stabilization member 16 travels through thebody tissue during installation. In this regard, those skilled in theart will appreciate that a virtually limitless number of differentpathways that a stabilization member 16 may travel and this featuresprovides great flexibility to a surgeon user. In addition, due to theindependent aspect of the rotation of the stabilization member, rotationmay be actuated or independently controlled without moving the insertiondevice with respect to sleeve 22. In this regard, rotation ofstabilization member 16 may be rotated without downward exertion offorce upon the sleeve and/or anchor.

Referring now to FIGS. 3-5, exemplary embodiments of anchors that may beutilized with the invention are shown. Referring to FIG. 3, oneembodiment of an anchor 32 is shown and generally comprises a bonefastener such as a bone screw 32 with a head 34 and a shaft or shank 36having bone engaging threads. As shown in FIG. 3, screw 32 is cannulatedwith a central passage or lumen 38 extending along a central axis 39,however, non-cannulated screws may also be used. Head 34 includes a toolengagement surface or opening 40 configured to receive a driving tool toprovide torque and drive the screw into bone. In one embodiment, screw32 is a polyaxial screw assembly that has a coupling element 42pivotably coupled to, head 34 of screw 32. A wedge 43 and clamp assembly45 may be housed within coupling element 42 to facilitate locking thescrew 32 with respect to coupling element 42. In this regard, screw 32is capable of rotating within coupling element 42 to selectably assume aplurality of angles. Referring to FIGS. 4-5, another exemplaryembodiment of a bone screw 32 is shown. Still another example of apolyaxial screw that may be used with the present invention is describedin U.S. Pat. No. 7,503,924, the entire contents of which areincorporated by reference.

Referring to the embodiments of FIGS. 3-5, coupling element 42 isconfigured and adapted to receive the stabilization member 16. Ingeneral, coupling element 42 includes a U-shaped body 44 defining achannel 26 in which stabilization member 16 may be locked or fixed inplace by, for example, a locking cap. In alternate embodiments,alternative means of rigidly coupling stabilization member 16 to ananchor may be used by those skilled in the art, including alternativeconfigurations of coupling elements and locking devices or methods. Inone embodiment, coupling element 42 includes features to couple withsleeves 22, 24.

In the illustrated embodiment, a sleeve may extend from the anchors 12,14 and provide a portal or passageway through the body of a patient toaccess anchors 12, 14. Referring to FIGS. 6-7, one embodiment of asleeve 50 according to the invention is shown comprising cannula 54extending from a proximal end 56 to a distal end 58 along an axis 60. Acentral channel 62 extends axially through sleeve 50. In this regard,cannula 54 generally comprises an extended tube with a generallycylindrical top portion 64 and a pair of generally rigid arms 66, 68extending axially from top portion 64 in a distal direction. Slots oropenings 76 extend along the lateral sides of sleeve 50 to provideaccess to central channel 62 of sleeve 50. Sleeve 50 may be made of anymaterial suitable for surgical instruments. In one preferred embodiment,sleeve 50 may be made of a metallic material.

In operation, arms 66, 68 of sleeve 50 may include a retainer portion 82at its distal end to attach an anchor to the distal end of sleeve 50. Inthis regard, arms 66, 68 may include projections 84 extending laterallyinward from the distal end to engage a corresponding feature on theanchor to provide additional retention capability.

When sleeve 50 is assembled to an anchor, as shown in FIG. 1, couplingelement 42 of bone screw 32 is received within retainer portion 82 at adistal end 58 of sleeve 50. In this regard, retainer portion 82 maysnappably or resiliently receive the coupling element 42 of screw 32.The inner wall 85 of retainer portion 82 is shaped to conform to theouter perimeter of coupling element 42 such that when arms 66, 68 engagean anchor, the coupling element 42 of screw 32 is rotationally andaxially fixed with respect to sleeve 50 or radially contained withinsleeve 50

Referring now to FIGS. 8-11, one embodiment of a stabilization member 16and insertion device 10 is shown. As shown in FIGS. 9-11, stabilizationmember 16 generally comprises an elongate rod 100 extending from aproximal end 102 to a distal end 104 along an axis 106. In oneembodiment, rod 100 is curved or arcuate along its length. However, inalternate embodiments, rod 100 may have any alternate shape. Accordingto one aspect of the embodiment, rod 100 includes a generally tapered orconical shaped nose or tip 108 at its distal end 104 to facilitateinsertion and installation of rod 100 into the body of a patient. Inalternate embodiments, tip 108 may have varied shapes and sizes.Proximal end 102 of rod 100 comprises a generally concave or roundedramped tip surface 109 angled with respect to longitudinal axis 106configured and dimensioned to interface or engage with actuating orpushing member 116 of insertion device 10.

Referring to FIG. 8, insertion device 10 generally comprises a means forclamping to or holding stabilization member 16 and means forcontrollably actuating or rotating the stabilization member 16 about thedistal end of the device. According to one variation, insertion device10 is an assembly generally comprising a pair of clamp members 110, 112pivotably attached adjacent a distal end 114 that may be selectablyactuatable to clamp, fix or hold the stabilization member 16 adjacentthe distal end thereof. Insertion device 10 additionally comprises adrive shaft or actuatable pusher assembly 116 extendable centrallywithin an outer guide tube 118 and linearly advanceable with respectthereto to facilitate the rotation or pivoting of the stabilizationmember 16 with respect to guide tube 118.

Referring again to FIGS. 9-11, in one embodiment, rod 100 may include apair of diametrically opposed indentations 124 spaced from proximal end102 of rod 100. In one variation, indentations 124 are generallyelongate grooves extending generally parallel with axis 106.Indentations 124 are configured and dimensioned to releasably rotatablyengage clamp members 110, 112 of insertion device 10 such that rod 100may pivot with respect to distal end 114. To attach rod 100 to clampmembers 110, 112, clamp members may be separatable to engage or snapinto indentations 124. In operation, once ridges cooperatively engageindentations 124, rod 100 may rotate or pivot about distal end 114.

One embodiment of a means for clamping comprises a left clamp member 110and a right clamp member 112 pivotably attached to a distal end of guidetube 118. A pair of openings 146 are provided adjacent the distal end ofguide tube 118 and receives clamp members 110, 112 therein to releasablyclamp to rod 100 such that rod 100 may rotate thereabout.

Referring to FIGS. 12 and 13, finger or flange portions 132 extendlaterally inward from clamp member sidewalls 134 and define a hole 136extending longitudinally therethrough. Clamp members 110, 112 may beassembled with flange portions 132 overlapping laterally and with holes136 aligned to receive a pin 138 and defining a pivot axis 140. In thisregard, the left and right clamp members 110, 112 may pivot with respectto each other about pin 138 and axis 140. A clamp ridge 142 may bedefined along a portion of the lower edge of each clamp member 110, 112such that when clamp members 110, 112 pivot about axis 142, ridges 142may move towards and away from each other to hold, clamp, or fix rod 100therebetween. According to one variation, rod 100 may be clamped or heldabout the upper portion thereof and with clamp members 110, 112 withinthe profile of rod 100 such that no portion of clamp members 110, 112extend or protrude beyond the radius of rod 100. In one embodiment, rod100 is generally cylindrical with a generally circular cross section andclamp members 110, 112 engage rod 100 on an upper portion of the rodspaced from the midline or diameter of the rod. In this regard, whenclamp members 110, 112 are in a clamping position to clamp or hold rod100, they are generally spaced apart a distance less than the diameterof the rod. It may be appreciated that as a result of such a design, rod100 may be loaded directly into an anchor receiver member at the rodclamping location without requiring additional space or room to allowthe clamp members to enter therein. Those skilled in the art mayappreciate that such a feature may be advantageous in facilitating theuse of legacy anchors or screws without the requirement that receiverportions be especially sized and dimensioned and/or retrofitted toaccommodate clamp members 110, 112.

Clamp members 110, 112 may be pivoted about axis 140 or actuated toclamp rod 100 remote from the distal end 114 via pin assembly 150 thatextends through guide tube 118. Referring to FIG. 14, in one variation aproximal end 152 of the pin assembly has a block or finger portion 154.As shown in FIG. 8, finger portion 154 is configured to engage aninterior of thumb nut 156 such that as the thumb nut is rotated, the pinassembly 150 may be linearly advanced or retracted as desired by a user.Thumb nut 156 is internally threaded and threadably engages collar 172.In this regard, threaded collar 172 may be axially constrained to guidetube 118 via C-clip 170. In alternate embodiments, threaded collar 172may be integrally formed with guide tube 118 such as via welding.

As best seen in FIGS. 19-20, pin assembly 150 is axially moveable withinguide tube 118 and the distal end of pin 158 is configured to engageclamp members 110, 112 to cause the clamp members to pivot about axis140. In a first position, shown in FIG. 19, the distal most tip 160 ofpin 158 is spaced from the distal most end 114 of tube 118 and spaceddistally from between protrusions 144 of clamp members 110, 112. In thisposition, clamp members 110, 112 may pivot apart such that rod 100 isnot clamped therebetween. Referring to FIG. 20, pin assembly 150 may beadvanced to a second position, shown in FIG. 20, with the distal mosttip 160 of pin 158 advanced distally between protrusions 144. In thissecond or clamped position, the ridges 142 of clamp members 110, 112 maymove towards each other to clamp or hold rod 100 therebetween.

A protrusion 144 extends inward from each clamp member sidewall,respectively. Protrusions 144 are generally cylindrical with roundedfree ends configured and dimensioned to linkingly engage openingsprovided in the distal end of insertion device 10. Protrusions 144 aregenerally coaxially positionable within openings 146 and aligned along apivot axis 148 defined through the center thereof. Pivot axis 148extends generally perpendicular to a central axial plane of rod 100 andclamp pivot axis 140. In this regard, when assembled to device 10, clampmembers 110, 112 are axially fixed and rotatable about the distal endthereof such that when rod 100 is clamped therebetween, rod 100 maypivot about axis 148 during installation in a patient.

One embodiment of a means for controllably actuating, pivoting, orrotating the stabilization member 16 about the distal end of insertiondevice 10 generally comprises a first member and a second member,wherein the first member is linearly translatable with respect to thesecond member along the longitudinal axis of the device and thestabilization member is linkingly engaged to the first member androtatably engaged to the second member. When the first member istranslated with respect to the second member along the longitudinalaxis, the stabilization member rotates about the second member.According to one embodiment, shown in FIG. 8, stabilization memberinsertion device 10 generally comprises an outer guide tube 118 and apusher assembly 116 concentrically disposable within screw extension orsleeve 50 to position a stabilization member 16 in relation to theattached screw(s).

As best seen in FIG. 8, pusher assembly 116 generally comprises a pushermember 160 integral to a threaded drive shaft or stein portion 162.Pusher assembly 116 is configured and dimensioned to fit within outertube 118 such that it is moveable with respect to outer tube 118 along alongitudinal axis 164. A knob 166 is internally threaded to mate withexternal threads of drive shaft 162 Such that rotation of knob 166causes linear translation of pusher assembly 116 with respect to outerguide tube 118 along axis 164. Pusher member 116 includes a distal end168 configured and dimensioned to pushingly and/or slidingly engageproximal end 102 of rod 100.

In operation, when knob 166 is rotated, drive shaft 116 is moveddownward or in the distal direction along axis 164 and distal end 168 ofpusher member 116 pushes or drives the proximal end 102 of rod 100downward or in the distal direction and causes rod 100 to rotate orpivot about pivot axis 148. In this regard, referring to FIGS. 21-24,rod 100 is moveable from a generally upright orientation or position ora position wherein axis 106 is aligned with or parallel to axis 164(FIG. 21) to a more horizontal orientation or position or a positionwherein axis 164 is perpendicular or angled with respect to axis 106(FIG. 24). Thus, rod 100 may be advanced through sleeve 50 and installedin a patient utilizing a minimally invasive approach. As describedabove, in one embodiment stabilization member 16 is rotatably actuatableby insertion device 10 independent of movement along the axis of thesleeve, i.e., the stabilization member 16 may be rotated by insertiondevice 10 anywhere along the length of the sleeves 22, 24.

A handle 180 may be provided to facilitate insertion of device 10 intosleeves 22, 24. A longitudinal or axial stop may be provided along theexterior of insertion device 10 to ensure that the insertion device androd attached thereto extends a sufficient length into sleeves 22, 24,such that rod 100 may be positioned sufficiently proximate to anchors12, 14 attached to the distal ends of sleeves 22, 24.

Surgical techniques or methods using the above described system anddevice will now be described. According to one embodiment of the presentinvention, anchors 12, 14 may be implanted into the vertebraepercutaneously, minimally invasively, or through an open or mini-openprocedure. In one exemplary embodiment, at least one of the anchors 12,14 is attached to, mounted on, or retained in sleeve 50, and the sleeve50 and attached anchor are inserted through an open incision, a tube orcannula, or directly through the skin and tissue of the patient toimplant the anchor into bone, such as the pedicles of a vertebrae. Inalternate embodiments, anchors 12, 14 can be implanted into bone withouta sleeve 50 attached thereto, and sleeve 50 may be mounted on an anchorafter it is implanted. For example, as shown in FIG. 25, according toone embodiment, anchors 12, 14, may be installed utilizing a retractorsystem 190, and one of the anchors 12, 14 may have a sleeve attachedthereto while one or more additional anchors does not have a sleeveattached. One exemplary retractor system 190 that may be utilized isdisclosed in U.S. patent application Ser. No. 11/422,511, the entirecontents of which are incorporated herein by reference. In anotherexemplary embodiment, shown in FIG. 1, both anchors 12, 14 may have asleeve attached thereto.

Any imaging system known to those skilled in the art may be utilized todetermine and locate optimum placement and orientation of the anchors inthe vertebrae and/or to identify locations for entry of the anchors.Other methods known by skilled artisans for locating and placing anchors12, 14 into the vertebrae may be also used, including, but not limitedto, a CT scan or x-ray, any known viewing instrument or apparatus,endoscopic, and microscopic monitoring.

Any known methods of locating and preparing the pedicle for screwimplantation may be utilized. In this regard, according to one knownminimally invasive technique, after location of the entrance point,instrumentation of the pedicle may begin with the insertion of acannulated needle through the skin of a patient to the intersection ofthe facet and transverse process of a vertebral body to which an anchoris to be implanted. A Kirschner wire or guidewire may be insertedthrough the needle cannula and into the pedicle. Successive dilationcannulas may be subsequently inserted over the guidewire to dilate thefascia and muscle until a working cannula is large enough to accommodateanchor 12 or 14. All but the largest cannula may be removed from theworking cannula to expose a passageway through the skin to the pedicleor insertion site. In one embodiment, a hole in the pedicle may beprepared by placing a cannulated drill and/or tap over the guidewire andthrough the working cannula to prepare the pedicle for screw insertion.In other embodiments, the pedicle may be prepared with other instrumentsknown in the art, including but not limited to an awl, a trocar, and aneedle.

Any known methods of installing a pedicle screw into a prepared pediclemay be utilized. In this regard, according to one known minimallyinvasive technique, a cannulated anchor, such as screw 32 attached tosleeve 50, may be placed over the guidewire and advanced through theworking cannula to the prepared pedicle. A driving tool such as acannulated screw driver may be used to rotate screw 32 and threadedlyengage screw 32 to the bone. Sleeve 50 may follow screw 32 to the boneand the screw driver and guidewire may be removed. The working cannulamay also subsequently be removed, leaving the sleeve 50 and screw 32secured to the bone.

With the anchors 12, 14 secured to the bone and at least one sleeve 50extending from at least one anchor, stabilization member 16 may beinstalled between anchors 12, 14 utilizing insertion device 10. In thisregard, stabilization member 16 is positioned on insertion device 10 andmay be inserted into sleeve 50 with the stabilization member 16initially in a generally vertical position (as shown in FIGS. 21-22). Asinsertion device 10 is advanced in the distal direction within sleeve 50and shaft 116 is moved in the distal direction, rod 100 rotates orpivots about pivot axis 148 to a more horizontal position (as shown inFIG. 24). In this regard, insertion device 10 moves stabilization member16 in a distal direction toward anchors 12, 14. The proximal end of rod100 swings outward through opening 76 of sleeve 50 and the distal tip108 of stabilization member 100 is advanced toward the channels 26 of anadjacent anchor 14. In one exemplary embodiment, as the insertion device10 is advanced distally into sleeve 50 and shaft 116 is advanceddistally with respect to the outer guide tube 118 of insertion device10, the tip 108 of stabilization member 100 follows a generallyelliptical path entering the patient through a first opening andtraveling toward the second anchor 14 and through the channel 26 of thesecond anchor. With rod 100 in a more horizontal position, rod 100 maybe then inserted into the channel 26 of the first anchor 12 by advancingthe rod insertion tool 10 distally toward the distal end of sleeve 50.According to one variation, the clamp members 110, 112 fit withinchannel 26 of anchor 12 such that rod 100 may be loaded into the anchorat the same axial location as the clamp members 110, 112 grip or clampthe rod. Sufficient clearance, space or room is also provided within thechannel that clamp members may be radially separated apart to release ordisengage rod 100 so as to leave rod 100 installed within channel 26

The clamp members 110, 112 may be unclamped from rod 100 to allow thestabilization member 16 to be removed from the insertion device. Oncestabilization member 16 is placed within anchors 12, 14 to the desiredposition, a cap and/or set screw may be driven downward, such as throughsleeve 50, to contact stabilization member 16 and fix stabilizationmember 16 to anchors 12, 14. In this regard, a driving tool may beplaced through the central channel of sleeve 50 to tighten the capand/or set screw against the stabilization member until thestabilization member is firmly seated in coupling element 42 of at leastone of anchors 12, 14.

With reference to FIGS. 26-38, various embodiments of stabilizationmember insertion devices are shown. These stabilization member insertiondevices may be used in open surgical procedures, mini-open surgicalprocedures, and/or minimally invasive surgical procedures, for example.In particular, the insertion devices may be suitable to deliver anelongate stabilization member, such as a rod, to the surgical siteusing, for example, an open, mini-open, percutaneous orminimally-invasive method. In addition, a retractor may be used with thesurgical procedure to provide the surgeon sufficient clearance toperform the procedure and, therefore, the instruments used for such aprocedure are preferably sized and designed to fit easily within theopening created during the surgery. Although various embodiments aredescribed with reference to certain surgical procedures, it should beunderstood that any suitable surgical technique may be selected.

Referring now to FIGS. 26-27, an alternative embodiment of astabilization member insertion device 300 is shown for use in aminimally invasive vertebral stabilization system. The system mayinclude at least one anchor 232, an elongate stabilization member 200,and the insertion device 300. The anchor 232 includes a head 234 and ashaft or shank 236, for example, having bone engaging threads. Theanchors 232 may include bone fasteners, such as polyaxial screws, bonescrews, hooks, etc. with a coupling element 242 attached thereto. Thecoupling element 242, such as a tulip element, yoke, or the like, may beprovided to couple the elongate stabilization member 200 to the anchor232. Clamp and/or wedge elements, as discussed above, may be used tosecure the anchor 232 and the coupling element 242. Unlike the sleevesystems discussed above, the anchors 232 may be connected to one or moreextended tabs 244. The extended tabs 244 may eliminate the need for aninstrument-based sleeve by incorporating the sleeve functionality intothe anchor 232. The extended tabs 244 may be separated and removed fromthe anchor 232 after the construct is complete.

With reference to FIGS. 28A-E, an embodiment of a coupling element 242having extended tabs 244 is shown. One or more extended tabs 244 definean open central portion 258 and a central longitudinal axis 260. Theextended tabs 244 may extend upwardly from an upper portion of thecoupling element 242 and/or anchor 232. The extended tabs 244 may eachhave a generally elongate curved body, for example, to mimic a sleeve.The extended tabs 244 may include a pair of diametrically opposedextended tabs 244 defining opposed longitudinal openings. Thelongitudinal openings may provide lateral access to and from the opencentral portion 258. For example, a portion of the elongatestabilization member 200 may be extendable through the longitudinalopenings. In addition, a portion of the insertion device 300 may beextendable through the open central portion 258. Although two extendedtabs 244 are exemplified, any suitable number, shape, and design ofextended tabs 244 may be utilized to provide access for the elongatestabilization member 200 and/or insertion device 300.

The extended tab 244 may be comprised of a multi-part component. Forexample, the extended tab 244 may include a first extension element 246connected to the coupling element 242 and/or first anchor 232 at a breakpoint 243 and a second extension element 248 connected to the firstextension element 246. The break point 243 may allow the extension tabs244 to be easily removed, for example, after the stabilization member200 has been secured to the anchor 232. The second extension element 248may be connected to the first extension element 246 at a connectionpoint 250. The connection point 250 may include, for example, a dovetailand/or welded connection. The interior portion of the first extensionelement 246 may be threaded 245, for example, to accept a threadedlocking cap. The interior portion of the second extension element 248may be smooth or threaded, for example. Although two extension elements246, 248 are exemplified, any suitable number, shape, and design of theextension elements 246, 248 may be used to create the extended tabs 244.

The extended tabs 244 may also comprise additional features, such as oneor more indentations 252 to accept instrumentation, for example, for rodreduction, screw insertion, tab removal, deformity correction, or thelike. As shown in FIG. 28D, a distal end of the second extension element248 may accept a sleeve 254, for example, to provide additionalstructural support during rod reduction, tightening of the locking cap,compression/distraction, rod passage, general tulip manipulationmaneuvers, or the like. As shown in FIG. 28E, the second extensionelement 248 may accept a sleeve 256 having a built-in fulcrum, forexample, for use during compression/distraction maneuvers. The extendedtabs 244 may be constructed to be substantially rigid, such that thetabs 244 are able to guide the insertion instrument 300 to anchor 232.

Referring to FIGS. 29A and 29B, the anchor 232 may be deliverable to avertebral body of a patient through an opening. After the anchor 232 issecured to the vertebral body, the elongate stabilization member 200 maybe inserted into the opening and articulated into position to be securedto the anchor 232. The elongate stabilization member 200 may be in theform of a rod. The rod may have a substantially straight shape or acurvilinear shape. The stabilization member 200 may have at least oneindentation along its length (as shown in FIGS. 9-11), for example, suchthat the insertion device 300 may clampably link to the stabilizationmember 200 about the indentation(s). The elongate stabilization member200 extends from a proximal end 202 to a distal end 204. A portion ofthe proximal end 202 may be configured and dimensioned to interact withthe insertion device 300. The proximal end 202 may be angled withrespect to a longitudinal axis of the stabilization member 200, and theproximal end 202 may define a concave surface.

The insertion device 300 releasably and rotatably links to the elongatestabilization member 200. FIGS. 29A and 29B show a close up view of theinsertion apparatus 300 holding the stabilization member 200 with (FIG.29A) and without (FIG. 29B) the coupling element 242 and extended tabs244 present. The insertion device 300 is configured and dimensioned tobe received between the extended tabs 244 and within the open centralportion 258 such that the insertion device 300 is moveable along orsubstantially parallel to the central longitudinal axis 260. Inparticular, the guide tube 318 of the insertion device 300 may be sizedand dimensioned to be received within the open central portion 258 andbetween the extended tabs 244. The elongate stabilization member 200 isdeliverable in a first orientation substantially parallel to the centrallongitudinal axis 260.

Instead of positioning the elongate stabilization member 200 through theopen central portion 258, the elongate stabilization member 200 may beoffset from the insertion device 300. The elongate stabilization member200 may be cantilevered off the insertion device 300 such that at leasta portion of the elongate stabilization member 200 is positioned outsidethe extended tabs 244. In particular, at least a portion of the elongatestabilization member 200 is not positioned within the open centralportion 258 and is positioned outside the extended tabs 244 and outsidethe open central portion 258. For example, the proximal end 202 of theelongate stabilization member 200 may not be contained within the opencentral portion 258 in the first orientation. Although a curved rod isdepicted and a distal end 204 may enter the open central portion 258, ifa straight rod were used instead, the distal end 204 would not enter theopen central portion 258 and would remain completely outside theextended tabs 244 and outside the open central portion 258.

Independent of movement of the insertion device 300 along orsubstantially parallel to the central longitudinal axis 260, theelongate stabilization member 200 is rotatably actuatable by theinsertion device 300 to extend in a second orientation angled withrespect to the first orientation to position the stabilization member200 in relation to the first anchor 232. The second orientation may beangled at about 90° relative to the first orientation, for example.FIGS. 30A and 30B are close-up side views of the insertion apparatus 300with the elongate stabilization member 200 articulated 90° with (FIG.30A) and without (FIG. 30B) the extended tab 244 and coupling element242 present. As is evident, the stabilization member 200 is pivoted intoa position to be attached to the anchor 232, for example, using couplingelement 242. The insertion and articulation of the elongatestabilization member 200 may be controlled with the use of fluoroscopy,for example, to help guide axial and rotation movements.

Once in position, a locking cap may be used to secure the stabilizationmember 200 in the coupling element 242. The stabilization member 200should be seated firmly in the coupling element 242 in order for theelements of the fixation device to be properly secured. The extendedtabs 244 may be removed, for example, after the elongate stabilizationmember 200 is locked in place.

The insertion device 300 may be operable to place the stabilizationmember 200 between one or more anchors 232. The insertion device 300 mayinclude an outer guide tube 318 having a pusher member 360 and/or a pinassembly including a pin 358 extending therethrough. FIGS. 31A and 31Bare close-up side views of the insertion apparatus 300 with the guidetube 318 removed. The pusher member 360 may be configured to enablepivoting of the elongate stabilization member 200. The pin assemblyincluding pin 358 may be configured to enable locking and unlocking ofthe elongate stabilization member 200 to the insertion device 300.

Similar to the clamp members discussed above, the elongate stabilizationmember 200 may be releasably clampable to the insertion device 300between first and second clamping members 310, for example, at aclamping location spaced from a midline of the elongate stabilizationmember 200. As described for FIGS. 12 and 13 above, the first clampingmember 310 may include a first generally cylindrical protrusioninsertable into a distal portion of the insertion device 300 and thesecond clamping member 310 may include a second generally cylindricalprotrusion insertable into the distal portion of the insertion device300. The first and second clamping members 310 may be coupled by a pinextending through a first and second opening in the first and secondclamping members 310, respectively.

In operation, the stabilization member 200 may be attached to theclamping members 310 of the insertion device 300 in the first, insertionorientation, which is shown in FIG. 31A in an unlocked position. Theclamping members 310 may be locked into position by actuating the pinassembly. In particular, thumb nut 356 may be rotated in a firstdirection to linearly advance the pin 358 and engage the clampingmembers 310, which is shown in FIG. 31B. The thumb nut 356 may beinternally threaded to threadably engage the pin 358.

After the stabilization member 200 is locked in place, the stabilizationmember 200 may be pivoted into the second, deployed position as shown inFIG. 32A. A user may pivot the stabilization member 200 by squeezinghandles 380 of the insertion device 300 together. When a user squeezesthe handles 380, the pusher member 360 is advanced linearly to movelinking member 362, which is coupled to the clamping members 310,thereby pivoting the stabilization member 200. The pusher member 360 maybe coupled to the linking member 362 with coupling member 364.Similarly, the linking member 362 may be coupled to the clamping member310 with another coupling member 364. As shown in FIG. 27, the insertiondevice 300 may include a ratchet 382 coupled to the insertion device bycoupling member 384. The coupling members 364, 384, which act as pivotpoints, may include pins, for example. The ratchet 382 may be in theshape of a wheel having a plurality of teeth positioned around theperiphery. The ratchet 382 may be uni-directional to provide forcontrolled articulation of the stabilization member 200. The ratchet 382may be locked by a locking member 386, for example, having correspondingteeth designed to engage the teeth of the ratchet 382 when depressed. Inaddition, the handles 380 may be provided with one or more springelements 388 to control the pivoting mechanism and allow the handles 380to maintain an expanded position unless a force is applied.

After the stabilization member 200 is positioned in the coupling element242 and optionally coupled thereto (e.g., with a locking cap), theclamping members 310 may be unlocked by actuating the pin assembly inthe opposite direction. In particular, thumb nut 356 may be rotated in asecond direction, opposite to the first direction, to linearly retractthe pin 358 and disengage the clamping members 310, which is shown inFIG. 32B. The stabilization member 200 may then be released and removedfrom the insertion device 300, and the insertion device 300 may beremoved from the patient. If not already secured, the stabilizationmember 300 may be secured to the anchor or anchors 232 to complete theconstruct.

Referring to FIGS. 33-36, another embodiment of an insertion device 400is provided. Insertion device 400 is substantially similar to insertiondevice 300 except that the handles 480 are coupled to the pusher member460 with an additional linking member 466. FIGS. 33A-C show alternateviews of the insertion device 400 with the stabilization member 200 inthe first, insertion orientation. The insertion device 400 may includean outer guide tube 418 having the pusher member 460 and/or pin assemblyincluding pin 458 extending therethrough. The guide tube 418 may includea series of markings, as shown in FIG. 33A, to identify depth, forexample. FIGS. 34A and 34B show the insertion device 400 with thestabilization member 200 in the second, articulated orientation.

The pin assembly including pin 458 may be configured to enable lockingand unlocking of the elongate stabilization member 200 to the insertiondevice 400. FIG. 35A shows the pin 458 in an unlocked position. Thethumb nut 456 may be rotated to linearly advance the pin 458, engage theclamping members 410, and lock the stabilization member 200 to thedevice 400, which is shown in FIG. 35B. FIGS. 34B and 36B show the pinin a locked position with the stabilization member 200 articulated about90°. The pin 458 may unlock the clamping members 410, which is shown inFIG. 36A, by rotating the thumb nut 456 in the opposite direction.

The pusher member 460 may be configured to enable pivoting (e.g., fromabout 0° to 90°) of the elongate stabilization member 200 from theinsertion orientation to the final, installation orientation. The pushermember 460 may be advanced linearly to move linking member 462, which iscoupled to the clamping members 410. The pusher member 460 may becoupled to the linking member 462 and the linking member 462 to theclamping member 410 with coupling members 464. The pusher member 460 maybe advanced using handles 480, which are connected using a ratchet 482affixed by coupling member 484, which acts as a pivot point. The ratchet482 may include a uni-directional ratchet, for example, in the shape ofa wheel having a plurality of teeth positioned around the periphery. Theratchet 482 may be locked by a locking member 486, for example, havingcorresponding teeth designed to engage the ratchet 482 when depressed.

One of the handles 480 may be coupled to the pusher member 460 bylinking member 466. The other handle 480 may be coupled to a portion ofthe sleeve or outer guide tube 418. The linking member 466 may beattached to the handle 480 and/or the pusher member 460 by one or morecoupling members 468. The coupling members 464, 468, 484, which act aspivot points, may include pins, for example. The linking member 466 maybe provided, for example, to assist with disassembly and/or cleaning ofthe device 400. In addition, the handles 480 may be provided with one ormore spring elements 488 to control the pivoting mechanism and allow thehandles 480 to maintain an expanded position unless a force is applied.

Referring now to FIGS. 37A-37H, an alternative embodiment of astabilization member insertion device 500 is shown, which may besuitable for use, for example, in an open or mini-open surgicalprocedure. Insertion device 500 is substantially similar to insertiondevices 300 and 400 except that the handles 480 are coupled to thepusher member 560 with an alternative linking member 566. FIG. 37A showsa front view and FIG. 37B shows a side view of the insertion device 500in the first, insertion orientation. The insertion device 500 mayinclude an outer guide tube 518 having the pusher member 560 and/or pinassembly including pin 558 extending therethrough. The guide tube 518may include a series of markings, as shown in FIGS. 37A, to identifydepth of the instrument within the surgical opening, for example. FIGS.37C and 37D show a front view and side view, respectively, of theinsertion device 500 with the stabilization member 200 in the second,articulated orientation.

FIG. 37E shows a side view and FIG. 37G shows a cross-sectional view ofthe insertion device 500 in the first, insertion orientation, and FIG.37F shows a side view and FIG. 37G shows a cross-sectional view of theinsertion device 500 in the second, articulated orientation. As isevident in FIGS. 37G and 37H, a pin assembly including pin 558 mayextending through the outer guide tube 518. The pin assembly includingpin 558 may be configured to enable locking and unlocking of theelongate stabilization member 200 to the insertion device 500. Aspreviously described, the thumb nut 556 may be rotated to linearlyadvance the pin 558, engage the clamping members 510, and lock thestabilization member 200 to the device 500. The pin 558 may unlock theclamping members 510 by rotating the thumb nut 556 in the oppositedirection.

The pusher member 560 may be configured to enable pivoting (e.g., fromabout 0° to 90°) of the elongate stabilization member 200 from theinsertion orientation to the final, installation orientation. The pushermember 560 may be advanced linearly to move linking member 562, which iscoupled to the clamping members 510. The pusher member 560 may becoupled to the linking member 562 and the linking member 562 to theclamping member 510 with coupling members 564. The pusher member 560 maybe advanced using handles 580, which are connected using a ratchet 582affixed by coupling member 584, which acts as a pivot point. The ratchet582 may include a uni-directional ratchet, for example, in the shape ofa wheel having a plurality of teeth positioned around the periphery. Theratchet 582 may be locked by a locking member 586, for example, havingcorresponding teeth designed to engage the ratchet 582 when depressed.

One of the handles 580 may be coupled to the pusher member 560 bylinking member 566. The other handle 580 may be coupled to a portion ofthe sleeve or outer guide tube 518. The linking member 566 may beattached to the handle 580 and/or the pusher member 560 by one or morecoupling members 568. The coupling members 564, 568, 584, which act aspivot points, may include pins, for example. The linking member 566 maybe provided, for example, to assist with disassembly and/or cleaning ofthe device 500. In addition, the handles 580 may be provided with one ormore spring elements 588 to control the pivoting mechanism and allow thehandles 580 to maintain an expanded position unless a force is applied.In particular, each handle 580 may include a spring element 588positioned on an inner surface of the handle 580 and configured toengage another spring element 588 on the opposite handle 580. As shownin FIG. 37B when the handles 580 are expanded apart from one another,the elongate stabilization member 200 is positioned in the insertionorientation with the elongate stabilization member 200 positionedsubstantially parallel to the guide tube 518 of the insertion device500. When the handles are squeezed together and closer to one another asshown in FIG. 37D, the pusher member 560 moves linearly causing thelinking member 562 to pivot and moving the elongate stabilization member200 into the installation orientation with the elongate stabilizationmember 200 positioned substantially perpendicular to the guide tube 518of the insertion device 500.

Referring now to FIGS. 38A-38I, an alternative embodiment of astabilization member insertion device 600 is shown, which may besuitable for use, for example, in an open or mini-open surgicalprocedure. Insertion device 600 is substantially similar to insertiondevices 300, 400, and 500. FIG. 38A depicts a cross-sectional view, FIG.38B shows a front view, and FIG. 38C shows a side view of the insertiondevice 600 in the first, insertion orientation. FIGS. 38D and 38E show afront view and side view, respectively, of the insertion device 600 withthe stabilization member 200 in the second, implantation orientation.

FIG. 38F shows a side view and FIG. 38H shows a cross-sectional view ofthe insertion device 600 in the first, insertion orientation, and FIG.38G shows a side view and FIG. 38I shows a cross-sectional view of theinsertion device 600 in the second, articulated orientation. Similar tothe other devices described herein, the insertion device 600 may includean outer guide tube 618 having a central longitudinal opening extendingfrom a first end to a second end and including, for example, a series ofmarkings to identify depth of the instrument within the surgicalopening. The outer guide tube 618 may house the pusher member 660 and/orpin assembly including pin 658 extending through the central opening.The pin assembly including pin 658 may be configured to enable lockingand unlocking of the elongate stabilization member 200 to the insertiondevice 600, for example, by rotating the thumb nut 656. By rotatingthumb nut 656, the pin 658 may be moved linearly to engage or disengagethe clamping members 610 to the stabilization member 200. FIGS. 38F and38G show the pin 658 in the unlocked position such that the clampingmembers 610 are free to open and close, and FIGS. 38H and 38I show thepin 658 in the locked position such that the clamping members 610 arelocked in position to retain the elongate stabilization member 200.

The pusher member 660 may also be advanced linearly by squeezing thehandles 680 together. For example, the handles 680 may be squeezedtogether causing linking member 666 to move pusher member 660 linearly.By moving the pusher member 660 linearly, linking member 662 is causedto pivot and move the elongate stabilization member 200 about 90°relative to its initial position. The handles 680 may be furthercontrolled with a ratchet 682, which pivots about coupling member 684.The ratchet 682 may include a uni-directional ratchet, for example, inthe shape of a wheel having a plurality of teeth positioned around theperiphery. The handles 680 may be locked in a fixed position relative toone another by a thumb lever or locking member 686, for example.

One of the handles 680 may be coupled to the pusher member 660 bylinking member 666, and the other handle 680 may be rigidly affixed to aportion of the sleeve or outer guide tube 618. The linking members 662,666 may be attached using one or more coupling members 664, 668, forexample, such as pins which enable pivoting of the respective linkingmembers 662, 666. In addition, the handles 680 may be provided with oneor more spring elements 688 to control the pivoting mechanism and allowthe handles 680 to maintain an expanded position unless a force isapplied.

While the invention herein disclosed has been described with referenceto specific embodiments and applications thereof, numerous modificationsand variations can be made thereto by those skilled in the art withoutdeparting from the scope of the invention as set forth in the claims.

What is claimed is:
 1. An insertion device suitable for installing anelongate stabilization member in a first orientation and pivoting theelongate stabilization member to a second orientation, the devicecomprising: an outer guide tube having an elongate body extending from afirst end to a second end and having a central longitudinal openingextending therethrough; a clamping element including at least oneclamping member; a pin assembly extending through the centrallongitudinal opening of the outer guide tube, the pin assembly having afirst end engaged with an actuation member and a second end configuredto engage the clamping element, such that when the actuation member isactuated, at least a portion of the pin assembly moves and engages aportion of the clamping element; a pusher member extending through thecentral longitudinal opening of the outer guide tube having a first endconnected to a handle and a second end connected to the clampingelement, such that when the handle is depressed, the pusher member movesto cause the elongate stabilization member to pivot.
 2. The device ofclaim 1, wherein the handle includes a first handle connected to thepusher member by a first linking element and a second handle connectedto the outer guide tube.
 3. The device of claim 2, wherein the first andsecond handles are connected together by a ratchet in the shape of awheel having a plurality of teeth positioned around a periphery of thewheel.
 4. The device of claim 3, wherein the first and second handlesare locked in position relative to one another by depressing a lockingmember having teeth corresponding to and designed to engage the ratchet.5. The device of claim 1, wherein the pusher member is connected to theclamping element with a second linking element configured to pivot inresponse to linear motion of the pusher member.
 6. The device of claim1, wherein the elongate stabilization member comprises a rod.
 7. Thedevice of claim 6, wherein the rod has a curvilinear shape.
 8. Thedevice of claim 6, wherein the rod has at least one indentation alongits length, wherein the insertion device is clampably linked to thestabilization member about the indentation.
 9. The device of claim 6,wherein a proximal end of the rod is configured and dimensioned tointeract with the insertion device.
 10. The device of claim 9, whereinthe proximal end of the rod is angled with respect to a longitudinalaxis of the rod and wherein the proximal end defines a concave surface.11. The device of claim 1, wherein the second orientation is angled atabout 90° relative to the first orientation.
 12. An insertion devicesuitable for installing an elongate stabilization member in a firstorientation and pivoting the elongate stabilization member to a secondorientation, the device comprising: an outer guide tube having anelongate body extending from a first end to a second end and having acentral longitudinal opening extending therethrough; a clamping elementincluding at least one clamping member; a pin assembly extending throughthe central longitudinal opening of the outer guide tube, the pinassembly having a first end engaged with an actuation member and asecond end configured to engage the clamping element; and a pushermember extending through the central longitudinal opening of the outerguide tube having a first end connected to a handle and a second endconnected to the clamping element.
 13. The device of claim 12, whereinthe handle includes a first handle connected to the pusher member by afirst linking element and a second handle connected to the outer guidetube.
 14. The device of claim 13, wherein the first and second handlesare connected together by a ratchet in the shape of a wheel having aplurality of teeth positioned around a periphery of the wheel.
 15. Thedevice of claim 14, wherein the first and second handles are locked inposition relative to one another by depressing a locking member havingteeth corresponding to and designed to engage the ratchet.
 16. Thedevice of claim 12, wherein the pusher member is connected to theclamping element with a second linking element configured to pivot inresponse to linear motion of the pusher member.
 17. The device of claim13, wherein the elongate stabilization member comprises a rod.